MAGNEVIST INJECTION 469 mgml

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

GADOPENTETIC ACID, DIMEGLUMINE SALT

Disponível em:

BAYER (SOUTH EAST ASIA) PTE LTD

Código ATC:

V08CA01

Dosagem:

469 mg/ml

Forma farmacêutica:

INJECTION

Composição:

GADOPENTETIC ACID, DIMEGLUMINE SALT 469 mg/ml

Via de administração:

INTRAVENOUS

Tipo de prescrição:

Prescription Only

Fabricado por:

BAYER AG

Status de autorização:

ACTIVE

Data de autorização:

1990-04-27

Folheto informativo - Bula

Magnevist PI_SG_CCDS 9 _7June 2013 

1.NAME OF THE MEDICINAL PRODUCT 

Magnevist 0.5 mmol per ml solution for injection. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml contains 0.5 mmol gadopentetate dimeglumine (equivalent to 469.01 mg 
gadopentetate dimeglumine) as active ingredient. 

For full list of excipients, see section 
‘List of excipients’. 

3. PHARMACEUTICAL FORM 
Solution for injection. 

Clear, colourless to pale yellow solution. 
The physio-chemical properties of Magnevist listed below are: 

Osmolarity at 37 ºC (osm/l solution) 
1.44 
Osmolality at 37 ºC (osm/kg H
2
O) 
1.96 
Osmot. pressure at 37 ºC 
(atm) 
49.8 
(mPa) 
5.06 

Viscosity (mPa · s or cP) 
at 20 ºC 
4.9 
at 37 ºC 
2.9 

pH 
7.0-7.9 

4. CLINICAL PARTICULARS 

4.1 INDICATION(S) 

This medicinal product is for diagnostic use only. 

• Cranial and spinal magnetic resonance imaging (MRI) 

In
particular for the demonstration of tumours and for further differential-diagnostic 
clarification in suspected meningioma, (acoustic) neurinoma, invasive tumours (e. g. 
glioma) and metastases; for the demonstration of small and/or isointense 
tumours; in suspected recurrence after surgery or radiotherapy; for the differentiated 
demonstration of rare neoplasms such
as haemangioblastomas, ependymomas and 
small pituitary adenomas; for improved determination of the spread of tumours 
not of cerebral origin. 

Additionally in spinal MRI: Differentiation of intra and
extramedullary tumours; 
demonstration of solid tumour areas in known
syrinx; determination of intramedullary 
tumour spread. 

• Whole body MRI 

Including the facial skull, the neck region, the thoracic and abdominal space, the female 
Magnevist PI_SG_CCDS 9 _7June 2013 

breast, the 

Características técnicas

Magnevist PI_CCDS 9 _13 Apr 2018
1.NAME OF THE MEDICINAL PRODUCT
Magnevist 0.5 mmol per ml solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.5 mmol gadopentetate dimeglumine (equivalent to
469.01 mg
gadopentetate dimeglumine) as active ingredient.
For full list of excipients, see section ‘List of excipients’.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
The physio-chemical properties of Magnevist listed below are:
Osmolarity at 37 ºC (osm/l solution)
1.44
Osmolality at 37 ºC (osm/kg H
2
O)
1.96
Osmot. pressure at 37 ºC
(atm)
49.8
(mPa)
5.06
Viscosity (mPa · s or cP)
at 20 ºC
4.9
at 37 ºC
2.9
pH
7.0-7.9
4. CLINICAL PARTICULARS
4.1 INDICATION(S)
This medicinal product is for diagnostic use only.
• Cranial and spinal magnetic resonance imaging (MRI)
In particular for the demonstration of tumours and for further
differential-diagnostic
clarification in suspected meningioma, (acoustic) neurinoma, invasive
tumours (e. g.
glioma) and metastases; for the demonstration of small and/or
isointense
tumours; in suspected recurrence after surgery or radiotherapy; for
the differentiated
demonstration of rare neoplasms such as haemangioblastomas,
ependymomas and
small pituitary adenomas; for improved determination of the spread of
tumours
not of cerebral origin.
Additionally in spinal MRI: Differentiation of intra and
extramedullary tumours;
demonstration of solid tumour areas in known syrinx; determination of
intramedullary
tumour spread.
• Whole body MRI
Including the facial skull, the neck region, the thoracic and
abdominal space, the female
Magnevist PI_CCDS 9 _13 Apr 2018
breast, the pelvis and the active and passive locomotive apparatus.
In particular, Magnevist permits diagnostic information:
- For the demonstration or exclusion of tumours, inflammations and
vascular lesions;
- For determination of the spread and demarcation of these lesions;
- For the differentiation of the internal structure of lesions;
- For assessment of th